Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
NCT ID: NCT03628625
Last Updated: 2018-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2018-09-10
2018-12-10
Brief Summary
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Detailed Description
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Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week
letrozole administration with misoprostol raises the rate of complete abortion
Hypothesis:
In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Study group
3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
Letrozole 2.5mg
total dose 7.5 mg per day for 3 days
Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion
Control group
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
Placebo
Folic acid for 3 days
Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion
Interventions
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Letrozole 2.5mg
total dose 7.5 mg per day for 3 days
Placebo
Folic acid for 3 days
Misoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion
Eligibility Criteria
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Inclusion Criteria
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 25 kg/m2.
* Missed abortion.
Exclusion Criteria
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
18 Years
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Dr- dina yahia mansour
Lecturer of Obstetrics and Gynecology Ain Shams University
Locations
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Ain Shams University, Maternity Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Dina Mansour
Role: primary
Other Identifiers
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0005
Identifier Type: -
Identifier Source: org_study_id
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